FDA.reportPublic FDA data

ST Single Use Tip

Primary DI
07290016746433
Brand
ST Single Use Tip
Company
VIORA LTD
Model
AS47010
Catalog number
AS47010
Device description
ST Single Use Tip
Published
2025-06-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric
NUVMassager, Vacuum, Light Induced Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1
NUVMassager, Vacuum, Light Induced HeatingGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090221000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090221000REACTION SYSTEMViora , Ltd.2009-07-01NUV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016746440PackageGS110In Commercial Distribution
07290016746433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016746440072900167464407290016746440
07290016746433072900167464337290016746433

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin/body contouring systemAn assembly of devices that uses radio-frequency (RF) electromagnetic (EM) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within subcutaneous tissues to temporarily minimize the manifestation of cellulite and loose or wrinkled skin through a process of skin regrowth and tightening and local fat cell alteration/destruction. It typically consists of monopolar and/or bipolar applicators attached to an energy-producing generator, typically with a cooling module. The tissues are warmed to produce the desired therapeutic effect; simultaneous cryogen cooling of the epidermis may be employed. This device is not used for the treatment of malignancies.

Contacts#

Phone, Email table
PhoneEmail
888 415 1192CustomerCareUsa@sinclair.com

Regulatory Flags#

DUNS number
514612758
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016746044V-IPL HP BasicVTL43000VTL430002016-09-23
07290016746051V-IPL HP FullVTL43040VTL430402016-09-23
07290016746068V-IPL HP FullVTL43060VTL430602016-09-23
07290016746402V-FR HandpieceV-FR20022026-04-19
07290016746501V-FR TipVTO20022026-04-19
07290016746563V-IPL Optic set Full 6 filtersVTL43050-6VTL43050-62025-12-22
07290016746662V-FC TipVTL48014VTL480142025-05-22
07290016746457V-ST Single Use tipAS47000AS470002025-06-03
07290016746754Treatment Kit 2.0GM00030 (US)GM00030 (US)2025-06-03
07290016746464V-ST Single Use tipAS47000AS470002025-06-03
07290016746471V-VR HandpieceVTL48010VTL480102025-06-03
17290016746652V-FC TipAS70028AS700282025-05-22
07290016746785V-FC Pro FullVTL48015-FVTL48015-F2025-09-01
07290016746808V-FC Pro TipVTL48018VTL480182025-09-01
07290016746815V-FC Pro HandpieceVTL48017VTL480172025-09-01
07290016746716ConsoleMM40000-USMM40000-US2025-05-22
07290016746723ApplicatorMM01000-USMM01000-US2025-05-22
07290016746730TrolleyMM60000-USMM60000-US2025-05-22
07290016746747Disposable Delivery NozzleMM05000-2.0 (US)MM05000-2.0 (US)2025-05-22
07290016746495DermaFuseDER0110DER01102025-05-21

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Primary DI, Brand, Company table
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